Trial Evaluating the Safety of 2 Schedules of Cabazitaxel in Elderly Men With mCRPC Previously Treated With a Docetaxel

NCT02961257 | Completed Phase 3

• 1 other identifier: CABASTY
• Study Type: interventional
• Target: 196
• Locations: 2 countries
• Sites: 31

Brief Summary

The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.

Conditions

Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Number of grade ≥ 3 neutropenia and/or neutropenic complications

  To evaluate the incidence of grade ≥ 3 neutropenia (measured at Day 7 and Day 14) and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen. with two schedules of -+cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men with mCRPC previously treated with a docetaxel-containing regimen

  Up to 11 months

Secondary Outcomes (15)

• Dose reductions

  through study completion, an average of 40 weeks

• Radiological progression-free survival (rPFS)

  Up to 11 months

• Time to PSA progression

  Up to 11 months

• Time to first symptomatic Skeletal-Related Event (SRE) and incidence of SREs

  Up to 11 months

• Time to opioid treatment (if relevant)

  Up to 11 months

Other Outcomes (9)

• Proportion of patients achieving a best objective response of SD, PR or CR according to RECIST 1.1 specifically comparing those achieving >30% and >50% decrease in MDSC post-induction compared to those who did not achieve this reduction.

  Up to 6 months

• Proportion of patients achieving a >50% PSA response at 12 weeks and at any time specifically comparing those achieving >30% and >50% decrease in MDSC post-induction compared to those who did not achieve this reduction.

  Up to 6 months

• Radiological progression-free survival (rPFS) according to PCWG2 criteria for all patients, in relation to percentage MDSC change (% maximum change and those achieving >30% and >50% decrease)

  Up to 6 months

Study Arms (2)

Arm A

EXPERIMENTAL

Cabazitaxel 25 mg/m² intravenously over 1 hour on Day 1of a 3-week cycle, plus prednisone (or prednisolone) 10 mg orally given daily for a maximum of 10 cycles (ie 30 weeks of treatment). Prophylactic Granulocyte colony-stimulating factor G-CSF (Granocyte) will be injected from Day 3 to Day 7 after every administration of cabazitaxel.

Drug: cabazitaxel; Drug: Prednisone; Drug: Granulocyte colony-stimulating factor (G-CSF)

Arm B

EXPERIMENTAL

Cabazitaxel 16 mg/m2 on Day 1 and Day 15 of a 4-week cycle plus prednisone (or prednisolone) 10 mg per day up to 10 cycles (ie 40 weeks of treatment). Prophylactic Granulocyte colony-stimulating factor G-CSF (Granocyte) will be injected from Day 3 to Day 7 after every administration of cabazitaxel.

Drug: cabazitaxel; Drug: Prednisone; Drug: Granulocyte colony-stimulating factor (G-CSF)

Interventions

cabazitaxel DRUG

* Arm A : cabazitaxel 25 mg/m² on Day 1 of a 3-week cycle plus daily prednisone or * Arm B: cabazitaxel 16 mg/m² on Day 1 and Day 15 of a 4-week cycle plus daily prednisone. * Treatment will be continued for a maximum of 10 cycles unless there is documented disease progression or unacceptable toxicity. * Standard cabazitaxel premedication will be used

Also known as: Jevtana, XRP6258

Arm A; Arm B

Prednisone DRUG

Arm A:plus prednisone 10 mg orally given daily for a maximum of 10 cycles Arm B: plus prednisone 10 mg orally given per day up to 10 cycles

Arm A; Arm B

Granulocyte colony-stimulating factor (G-CSF) DRUG

Primary prophylaxis with Granulocyte Colony-Stimulating Factor (G-CSF) will be injected from Day 3 to Day 7 after every administration of cabazitaxel

Also known as: Granocyte

Arm A; Arm B

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient aged ≥ 65 years with mCRPC previously treated with docetaxel
• Medical or surgical castration with castrate level of testosterone (\< 50 ng/dl) based on the EAU definition of castrate level of testosterone
• Progressive disease according to PCWG2
• Histologically proven prostate carcinoma
• Health status allowing use of chemotherapy: G8 \> 14; or G8 score ≤ 14 with geriatric assessment concluding to reversible impairment allowing use of chemotherapy
• ECOG-PS 0, 1 or 2(ECOG-PS 2 should be related to prostate cancer)
• Adequate hematologic, liver and renal functions:
• Neutrophil count ≥1.5 109/L
• Haemoglobin ≥10 g/ dL
• Platelet count ≥100.109/L
• Total bilirubin ≤ 1 the upper limit of normal (ULN)
• Transaminases ≤ 1.5 ULN
• Serum creatinine ≤ 2.0 ULN
• Ongoing LHRH therapy at study entry
• Signed informed consent

You may not qualify if:

• History of severe hypersensitivity reaction (≥grade 3) to docetaxel
• History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
• Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
• Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix E)
• PS \>2 not related to prostate cancer disease
• G8 ≤ 14 with geriatric assessment contra-indicating standard cabazitaxel regimen
• Concomitant vaccination with yellow fever vaccine
• Patient who cannot be regularly followed or cannot answer to quality of life questionnaires because of psychological, social, familial or geographic reasons
• Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.

Sponsors & Collaborators

• Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie: lead

Study Sites (31)

Hôpital Jean Minjoz

Besançon, 25030, France

Location

Hôpital Saint André, CHU de Bordeaux

Bordeaux, 33075, France

Location

Clinique Pasteur-CFRO

Brest, 29229, France

Location

Centre Maurice Tubiana

Caen, 14000, France

Location

Polyclinique Saint-Côme

Compiègne, 60204, France

Location

CHU Henri-Mondor

Créteil, 94000, France

Location

Clinique Victor Hugo

Le Mans, 72000, France

Location

Centre Oscar Lambret Lille

Lille, 59000, France

Location

Hôpital Belle-Isle

Metz, 57045, France

Location

GHIRM

Montfermeil, 93370, France

Location

Institut de Cancérologie du Gard - CHU

Nîmes, 30029, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Universitaire Tenon

Paris, 75020, France

Location

Hôpital Cochin

Paris, 75679, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CHU de Rouen

Rouen, 76000, France

Location

Clinique Armoricaine de Radiologie

Saint-Brieuc, 22015, France

Location

HIA Bégin 69 avenue de Paris

Saint-Mandé, 94160, France

Location

Centre Hospitalier de Sens

Sens, 89100, France

Location

Hôpitaux universitaires de Strasbourg

Strasbourg, 67000, France

Location

Hôpital FOCH

Suresnes, 92151, France

Location

Centre de cancérologie Les Dentellières

Valenciennes, 59300, France

Location

Urologisch-onkologische Schwerpunktpraxis

Bernburg, 06406, Germany

Location

Uniklinik Köln, Urologie, Uro-Onkologie, spezielle urologische und Roboter-assistierte Chirurgie

Cologne, 50937, Germany

Location

Urologie und Kinderurologie Marienkrankenhaus Bergisch

Gladbach, 51465, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Universitäts-klinik für Urologie und Kinderurologie

Magdeburg, 39104, Germany

Location

Urologische Praxis am Hasselbachplatz

Magdeburg, 39104, Germany

Location

Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie,

Münster, 48149, Germany

Location

Studienpraxis Urologie

Nürtingen, 72622, Germany

Location

Related Publications (2)

• Oudard S, Ratta R, Voog E, Barthelemy P, Thiery-Vuillemin A, Bennamoun M, Hasbini A, Aldabbagh K, Saldana C, Sevin E, Amela E, Von Amsberg G, Houede N, Besson D, Feyerabend S, Boegemann M, Pfister D, Schostak M, Huillard O, Di Fiore F, Quivy A, Lange C, Phan L, Belhouari H, Tran Y, Kotti S, Helissey C. Biweekly vs Triweekly Cabazitaxel in Older Patients With Metastatic Castration-Resistant Prostate Cancer: The CABASTY Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Dec 1;9(12):1629-1638. doi: 10.1001/jamaoncol.2023.4255.

  PMID: 37883073 DERIVED

• Pobel C, Auclin E, Procureur A, Clement-Zhao A, Simonaggio A, Delanoy N, Vano YA, Thibault C, Oudard S. Cabazitaxel schedules in metastatic castration-resistant prostate cancer: a review. Future Oncol. 2021 Jan;17(1):91-102. doi: 10.2217/fon-2020-0672. Epub 2020 Dec 2.

  PMID: 33463373 DERIVED

MeSH Terms

Interventions

cabazitaxel; XRP6258; Prednisone; Granulocyte Colony-Stimulating Factor; Lenograstim

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Stephane OUDARD, MD, Ph.D

  Hôpital Européen Georges Pompidou, Oncology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: November 10, 2016
• Study Start: May 5, 2017
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: May 12, 2022

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); FR (23)